ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM

K033977 · Zeus Scientific, Inc. · JZO · Mar 22, 2004 · Immunology

Device Facts

• Record ID: K033977
• Device Name: ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: JZO · Immunology
• Decision Date: Mar 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Intended Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte™ TPO/Tg Test System is intended for the quantitative detection of IgG class antibody to 2 separate thyroid antigens (thyroid peroxidase (TPO) and thyroglobulin (Tg)) in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune thyroid diseases. This test is for In Vitro diagnostic use only.

Device Story

AtheNA Multi-Lyte™ TPO/Tg Test System is an in vitro diagnostic assay for detecting IgG autoantibodies against thyroid peroxidase (TPO) and thyroglobulin (Tg) in human serum. Used in clinical laboratory settings by trained personnel. The system utilizes multiplexed bead-based technology to measure antibody levels. Results are interpreted by clinicians alongside other clinical findings to assist in diagnosing thyroid-related autoimmune conditions. The device provides quantitative and qualitative data to support clinical decision-making regarding thyroid disease management.

Clinical Evidence

Bench testing and method comparison study. Evaluated 750 specimens (300 routine, 300 disease-state, 150 normal). Overall agreement with predicate: 95.6% for anti-TPO and 98.8% for anti-Tg. Clinical sensitivity: 100% (300/300) in clinically diagnosed patients. Clinical specificity: 93.2% (95% CI: 89.1-97.3%) in normal donors. Precision (intra/inter-assay) reported with %CVs ranging from 3.3% to 21.9%.

Technological Characteristics

Multiplexed bead-based immunological test system for the detection of IgG autoantibodies. Class II device under 21 CFR 866.5870 (Thyroid autoantibody immunological test system).

Indications for Use

Indicated for qualitative and quantitative detection of IgG autoantibodies to human thyroid peroxidase and/or human thyroglobulin in human serum to aid in the diagnosis of thyroid diseases.

Regulatory Classification

Identification

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 2 2004

Mr. Mark J. Kopnitsky Vice President, Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, NJ 08876

k033977 Re:

> Trade/Device Name: AtheNA Multi-Lyte™ TPO/Tg Test System Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid autoantibody immunological test system Regulatory Class: Class II Product Code: JZO Dated: December 18, 2003 Received: January 13, 2004

Dear Mr. Kopnitsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Arhellett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

(Appendix E)

510(k) Number (if known): H033977

Device Name: AtheNA Multi-Lyte™ TPO/Tg Test System

Indications for Use:

The Zeus Scientific, Inc. AtheNA Multi-Lyte™ TPO/Tg Test System is for the qualitative and quantitative detection of IgG autoantibodies to human thyroid peroxidase and/or human thyroglobulin in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801,109)

(Optional Format 1-

2-96)

A.P. Reever for M. Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033977